The U.S. Food and Drug Administration (FDA) approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization, according to a press release. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.
Veklury is the first treatment for COVID-19 to receive full FDA approval, the FDA said.
The agency also said its approval does not include the entire population that had been authorized to use Veklury under an Emergency Use Authorization (EUA), which was originally issued on May 1, 2020. In order to ensure continued access to the pediatric population previously covered under the EUA, the FDA revised the EUA for Veklury to authorize the drug’s use for treatment of suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg. Clinical trials assessing the safety and efficacy of Veklury in this pediatric patient population are ongoing, the agency said.
FDA Commissioner Stephen M. Hahn, MD, said, “The approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic.”
The FDA said the approval of Veklury was supported by the agency’s analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19.
One randomized, double-blind, placebo-controlled clinical trial (ACTT-1), conducted by the National Institute of Allergy and Infectious Diseases (NIAID) , evaluated how long it took for subjects to recover from COVID-19 within 29 days of being treated. A second randomized, open-label multi-center clinical trial of hospitalized adult subjects with moderate COVID-19 compared treatment with Veklury for five days and treatment with Veklury for 10 days with standard of care. A third separate, randomized, open-label multi-center clinical trial of hospitalized adult subjects with severe COVID-19 compared treatment with Veklury for five days and treatment with Veklury for 10 days.
Researchers evaluated the clinical status of subjects on Day 14. Overall, the odds of a subject’s COVID-19 symptoms improving were similar for those in the five-day Veklury group as those in the 10-day Veklury group, and there were no statistically significant differences in recovery rates or mortality rates between the two groups.
Evidence from another clinical trial – the Solidarity Therapeutics Trial coordinated by the World Health Organization (WHO) – indicated that remdesivir appeared to have little or no effect on 28-day mortality or the in-hospital course of COVID-19 among hospitalized patients.
The FDA granted approval and reissued the revised EUA to Gilead Sciences.
